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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorRodríguez, José
dc.contributor.authorMuñiz Mercado, Yadira
dc.date.accessioned2020-08-12T12:28:25Z
dc.date.available2020-08-12T12:28:25Z
dc.date.issued2012
dc.identifier.citationMuñiz Mercado, Y. (2012). Handling regulatory inspections [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/494
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract - As per the International Harmonization Guidelines (ICH) a regulatory inspection is the act by a regulatory authority (ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority (ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or CRO’s facilities, or at the other establishment deemed appropriate by the regulatory authority (ies). An inspection can happen at any time in any city or state. The mission is to protect consumers and enhance public health by maximizing compliance of regulated products and minimizing the risk associated with those policies. Inspections can cover finished human and veterinary drugs and biologics [9]. Key Terms - Board of Health (BoH), Inspections, Regulatory agenciesen_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2012;
dc.relation.haspartSan Juanen_US
dc.subject.lcshIndustrial safety--Evaluationen_US
dc.subject.lcshIndustrial safety--Law and legislationen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleHandling Regulatory Inspectionsen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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